Efficacy and safety of lubiprostone for the treatment of functional constipation in Chinese adult patients: A multicenter, randomized, double-blind, placebo-controlled trial
单位：[1]The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou 510000, Guangdong Province, China院本部中山大学附属第一医院[2]The Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou 310020, Zhejiang Province, China[3]The First Affiliated Hospital, Xi’an Jiaotong University, Xi’an 710061, Shanxi Province, China[4]The Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan 430030, Hubei Province, China华中科技大学同济医学院附属同济医院[5]The Nanfang Hospital, Southern Medical University, Guangzhou 510515, Guangdong Province, China[6]The Affiliated Hospital of Qingdao University, Qingdao 266000, Shandong Province, China[7]The Third Xiangya Hospital of Central South University, Changsha 410013, Hunan Province, China[8]The Qilu Hospital of Shandong University, Jinan 250012, Shandong Province, China.[9]The Wuhan Union Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan 430022, Hubei Province, China华中科技大学同济医学院附属协和医院[10]The Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China[11]The Second Affiliated Hospital of Nanchang University, Nanchang 330006, Jiangxi Province, China[12]General Hospital of the Western Theater of Chinese People's Liberation Army, Chengdu 610083, Sichuan Province, China[13]The First Bethune Hospital of Jilin University, Changchun 130021, Jilin Province, China.[14]The First Hospital of China Medical University, Shenyang 110122, Liaoning Province, China[15]The Peking University People’s Hospital, Beijing 100044, China[16]The Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China.首都医科大学附属北京友谊医院[17]The Zhongshan Hospital, Fudan University, Shanghai 200032, China[18]The Xiangya Hospital of Central South University, Changsha 410000, Hunan Province, China[19]The Second Xiangya Hospital of Central South University, Changsha 410011, Hunan Province, China
Objectives Functional constipation is a gastrointestinal disorder prevalent around the world. Lubiprostone is the first locally acting type-2 chloride channel activator to be used for treating constipation. This study aimed to evaluate the efficacy and safety of lubiprostone in Chinese adults with functional constipation. Methods This was a multicenter, randomized, double-blind, placebo-controlled study. Patients with functional constipation were randomized to receive either lubiprostone (24 mcg twice daily) or placebo for 4 weeks. The primary end-point was the frequency of spontaneous bowel movements (SBMs) during the first week of treatment. The secondary end-points included the median time of the first SBM, SBM frequency at weeks 2, 3 and 4, weekly response rate of SBMs, the stool consistency score and average number of complete spontaneous bowel movements (CSBMs) per week. Results In total, 259 patients were randomized, with 130 in the lubiprostone group and 129 in the placebo group. SBM frequency was higher in the lubiprostone group (4.88 +/- 4.09/wk) than that in the placebo group (3.22 +/- 2.01/wk) at week 1 (P < 0.0001). SBM frequency was also higher in the lubiprostone group at weeks 2, 3 and 4. The average number of CSBMs and the stool consistency score in the lubiprostone group were significantly higher than that in the placebo group at each week. No drug-related serious adverse events (AEs) occurred. The most commonly reported AE was nausea. Conclusion Lubiprostone was superior to placebo in treating Chinese patients with functional constipation, together with good safety profile.
基金：
National Natural Science Foundation of ChinaNational Natural Science Foundation of China (NSFC) [81770544, 81970479] Funding Source: Medline
第一作者单位：[1]The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou 510000, Guangdong Province, China
通讯作者：
通讯机构：[1]The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou 510000, Guangdong Province, China[*1]The First Affiliated Hospital, Sun Yat-Sen University No. 58, ZhongShan 2 Road. Guangzhou, PR China
推荐引用方式(GB/T 7714)：
Xiao Yinglian,Dai Ning,He Shuixiang,et al.Efficacy and safety of lubiprostone for the treatment of functional constipation in Chinese adult patients: A multicenter, randomized, double-blind, placebo-controlled trial[J].JOURNAL of DIGESTIVE DISEASES.2021,22(11):622-629.doi:10.1111/1751-2980.13058.
APA：
Xiao Yinglian,Dai Ning,He Shuixiang,Tian De'an,Liu Side...&Chen Minhu.(2021).Efficacy and safety of lubiprostone for the treatment of functional constipation in Chinese adult patients: A multicenter, randomized, double-blind, placebo-controlled trial.JOURNAL of DIGESTIVE DISEASES,22,(11)
MLA：
Xiao Yinglian,et al."Efficacy and safety of lubiprostone for the treatment of functional constipation in Chinese adult patients: A multicenter, randomized, double-blind, placebo-controlled trial".JOURNAL of DIGESTIVE DISEASES 22..11(2021):622-629
